Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms, Juxtarenal Aneurysms
Conditions
Brief summary
The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.
Interventions
DEVICEZenith(R) Fenestrated AAA Endovascular Graft
The Zenith(R) Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm
Exclusion criteria
* Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal * Renal artery stenosis greater than 50 percent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Success | 6 months | Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm. A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair. A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zenith® Fenestrated AAA Endovascular Graft The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | No long-term (3-5 year) consent | 6 |
| Overall Study | Still be eligible for follow-up | 7 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Zenith® Fenestrated AAA Endovascular Graft |
|---|---|
| Age, Continuous | 75.3 years STANDARD_DEVIATION 7.4 |
| Gender Female | 9 Participants |
| Gender Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 42 |
| serious Total, serious adverse events | 4 / 42 |
Outcome results
Primary
Number of Participants With Treatment Success
Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of all vessels targeted by a fenestration intra-operatively), and freedom from the following: type I or type III endoleaks, AAA-related serious adverse events, AAA-related major complications, and aneurysm enlargement greater than 0.5 cm. A serious adverse event is defined as any occurrence of death, aneurysm rupture, or conversion to open surgical repair. A major complication is defined as any occurrence of Q-wave myocardial infarction, congestive heart failure, cardiac ischemia requiring intervention, renal failure requiring permanent dialysis, bowel obstruction, ischemia, or fistula, stroke with permanent deficit, or paralysis.
Time frame: 6 months
Population: Two patients were lost to follow-up and did not have CT data at 6 months. Patients treated with the Zenith® Fenestrated AAA Endovascular Graft was compared to propensity score matched patients treated with the Zenith® AAA Endovascular Graft (NCT00196092, link to 5-year study results provided).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zenith® Fenestrated AAA Endovascular Graft | Number of Participants With Treatment Success | 39 participants |
Comparison: Patients treated with the Zenith® Fenestrated AAA Endovascular Graft were compared with matched patients treated with the Zenith® AAA Endovascular Graft.p-value: 0.02Exact test for matched pairs